Ashley Preston Email & Phone Number

Boston, Ma, Us

Cambridge , Ma, Us

- Building and leading the Global Regulatory Affairs and Quality Assurance organization at Syros, with responsibility for all Regulatory Affairs, Quality Assurance and Medical Writing activities to support multiple clinical-stage assets.- Leading the Regulatory team to design and execute Global Regulatory Strategies for the pipeline molecules throughout their development life cycle.- Leading the Quality team to actively promote a Quality Compliance Culture, and to ensure GXP compliance throughout Syros’ drug development operations.- Leading the Medical Writing team to deliver high-quality, submission-ready content for all regulatory submissions.- Building and leading Operational Excellence within the Clinical/Medical organization at Syros, optimizing the effectiveness of the organization to deliver on the development pipeline and the long-term strategic plan. - Leading Operational Excellence workstreams to integrate ideas, provide innovative solutions, and develop best practices for the Clinical/Medical organization, to efficiently scale up with a growing development pipeline, while operating effectively. - As a member of the Syros Extended Management Team, drive the strategic direction and operational effectiveness of the organization.

Cambridge , Ma, Us

Cambridge , Ma, Us

- Establishing and leading the Global Regulatory Affairs (GRA) function at H3 Biomedicine, with responsibility for the design and execution of Global Regulatory Strategies for the clinical development portfolio, including three clinical stage assets and multiple pre-clinical/discovery programs.- As a member of the Clinical Development Leadership Team (CLDT), driving the strategic direction and operational effectiveness of the Clinical Development Programs.

Boston, Massachusetts, Us

- Leading a new Global Regulatory Affairs (GRA) function, and a new global team, with responsibility for Regulatory Science, Process, Compliance & Training, and a member of the GRA Operations Leadership Team.- Driving the design and execution of the ReSPCT book of work, to: i) promote the institutionalization of Regulatory Science principles and initiatives across GRA; ii) actively manage and continuously improve the GRA quality document landscape; iii) evaluate the GRA compliance status and implement risk mitigation strategies; and iv) actively manage the GRA training matrix and on-boarding program(s). - Leading the creation and implementation of an integrated GRA ‘HealthCheck’ platform, consolidating key data from across the function for assessment of KPIs, compliance and project milestones, enabling informed decision-making for risk mitigation, CAPAs and resource allocation. - Developing and maintaining collaborative internal and external stakeholder relationships, to drive alignment on the implementation of ReSPCT initiatives.

Darmstadt, Hessen, De

- Leadership and management of all Regulatory & Scientific Policy matters in the International Region (Asia-Pacific, China, Japan, Russia/CIS, Middle-East, Africa).- Engaging with Regulatory Agencies on policy topics relevant to the research, development and commercial activities of Merck Serono.- Actively monitoring the regulatory policy landscape across the International Region to identify, analyse and influence policy changes, thereby maximizing opportunities for, and mitigating risks to, Merck Serono’s development and commercial activities.- Representing Merck Serono on Industry Trade Association committees (PhRMA, EFPIA, IFPMA, etc) for subject matter that is relevant to the interests of International markets, contributing to the development of multiple position papers.- Providing International Regulatory Policy & Intelligence support to the global development teams for the design and execution of global regulatory/development strategies.

Tokyo, Jp

- Leadership of regulatory activities in the Asia-Pacific region (ex-Japan), and membership of the Takeda Asia-Pacific R&D Leadership Team.- Led the design and implementation of regional regulatory strategies – integrating Asia-Pacific markets into global development program(s) – and driving NDA submissions for multiple products, including: Alogliptin (VIPIDIA), Vonoprazan, Dexlansoprazole, Azilsartan (EDARBI), Brentuximab Vedotin (ADCETRIS), Mifamurtide (MEPACT). - As a member of the Takeda APAC R&D Leadership Team, led negotiations and cross-functional collaborations with global colleagues to ensure alignment on the deliverables for successful product development and registration in Asia-Pacific. Also, I led the regulatory component of negotiations and collaborations with CRO(s) and other consultants.- Recipient of the Takeda Global Award in November 2010 for ‘Establishing the APAC Regional Regulatory Affairs Function and Creating Integrated Regulatory/Development Strategies for Takeda Products in APAC’. - Established the regional regulatory affairs function, including team selection, training and development.- Actively monitored the regional regulatory landscape to identify, assess and act on opportunities and/or mitigate risks to the company development and commercial activities.

- Global strategic regulatory planning and submission activities, across three individual projects, including clinical studies in Phases 1, 2 & 3. - Writing, compiling and reviewing global regulatory submissions, including: IND Annual Reports, Type B/C Meeting Briefing Packages, IND Safety Reports, Chemistry Manufacturing & Controls data submissions, Clinical Protocol submissions (Phase 1, 2 & 3), Investigator Brochures, CHMP Scientific Advice Requests, Clinical Trial Applications/IMPD (Phase 3).- Leadership of pivotal interactions, meetings and negotiations with Regulatory Agencies including FDA and EMA.- Leading the regulatory component of negotiations and collaborations with Contract Manufacturer(s), CROs and other external consultants.

Brentford, Middlesex, Gb

- Registration of new products and maintenance of existing registrations for the Australian and New Zealand markets, across multiple therapeutic areas, including HIV/anti-infective, respiratory, cardiovascular/metabolic and CNS.- Management of interactions and negotiations with TGA and MedSafe.- Contribution to internal projects including creation/maintenance of various SOPs, processes and databases.

Melbourne, Au

Developed, lectured and assessed a single semester Pharmacology course for students studying Myotherapy.

Deakin, Australian Capital Territory, Au

Contracted as an Assessor/Examiner for the Medicines Australia Continuing Education Program (CEP), assessing Module 5 'Understanding the Clinical Evidence'.

Phd, Pharmacology

Bsc (Honours), Pharmacology